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Medtronic - Sofradim Production

France · Trévoux

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 0Class II 6Class III 0

plus 24 registration records and 43 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class III 4Class IV 1

32 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States24 registration records, 43 510(k), 0 PMA

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: SOFRADIM PRODUCTION

FDA 510(k) clearances by year

22001

12003

32004

22005

22007

32008

12009

22010

42011

32012

12013

42014

22015

12017

22018

12019

22022

22024

32025

12026

FDA listed device types

Mesh, Surgical, Absorbable, Abdominal Hernia 1Mesh, Surgical, Collagen, Large Abdominal Wall Defects 1Surgical Film 1Mesh, Surgical 1Mesh, Surgical, Polymeric 1Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253956	ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)	2026-05-21
US	K253125	Parietene Flat Sheet Mesh	2025-10-24
US	K250869	Parietene Macroporous Mesh (PPM5050 )	2025-04-23
CA	71975	URETEX TO SYSTEM	Class III
CA	72400	PROSUP PELVIC FLOOR REPAIR MESH	Class III
CA	72401	PROSUP PELVIC FLOOR REPAIR MESH - POLYESTER	Class III

Medtronic - Sofradim Production

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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